Present: Tom Summerfelt (moderator), Crystal Blyler, Jean Campbell, Sally Clay, Dianne Cote, Sita Diehl, Sarah Diwan, Zahira Duvall, Janine Elkanich, Susan Essock, Rise Goldstein, Louetta Hix, Matt Johnsen, Anika Keens-Douglas (notetaker), Ed Kramer, Sandy Lint, Danyelle Mannix, Brian McCorkle, Jo-Anne O’Connor, Ruth Ralph, Sally Rogers, Mark Salzer, Bonnie Schell, Steve Segal, Carol Silverman, Joe Sonnefeld, Greg Teague, Sharon Togut

Proposals around common induction

Draft Screening Questionnaire

                              Health Section of Common Protocol

                                                  Housing Section of Common Protocol

                                                  Substance Use Section of Common Protocol

Release of Records

Steve Segal voiced some concern about the language used in the suggested common induction that was posted on the listserv for review. He stated that language used should not waive consumer rights, should include current and previous treatment, and should be very clear, especially about crossover. Susan Essock and JoAnne O’Connor added that it was more important for the language to be more flexible and less specific to allow tailoring by sites.

Greg noted that his proposal was for a common process, and agreed that there should be latitude across sites.

The Steering Committee agreed that there should be flexibility in the language, but the writing should let the participants know that they are part of a study with information about the groups they maybe placed in and its responsibilities, and that they have a fifty-fifty chance of being assigned to any group. The writing should positively describe the fact that crossover is not encouraged, but would not be a reason for elimination from the study.

Zahira Duvall expressed concern that this may cause problems with the IRB and consumer groups.

The motion regarding common induction stated that the language should include the two elements of randomization with a description of each of the conditions and the individual’s responsibilities within each of the conditions. Crossover language would not be required where COSP is considered an aspect of usual care.

Bonnie Schell seconded the motion.

Motion made by Matt Johnsen, and was seconded by Tom Summerfelt. The draft screening questionnaire had been posted on the listserv for previous viewing.

The questionnaire was read by the moderator, and opened for discussion by the committee. Steve Segal raised the question of whether people on conservatorships would be eliminated. The group discussed the fact that IRBs have different rules, so conservators and conservatees would both need to be involved in gaining consent. It was noted too that residential program participants would meet the criteria to be included in the study. The Coordinating Center would need to know if sites had a process for screening.

The group agreed that the draft screening questionnaire would be administered to the individual, conservators would also be advised where this is applicable. The group agreed to exclude the follow up question, "If YES, what is your diagnosis?". The questionnaire should also include a summary list of the inclusion/exclusion criteria for all sites, and other requirements could be site-specific. Page 3 would thus be required for all sites, while Pages 1 and 2 would be optional, used as an example of one method for data collection, and serve as a reference.

The health section of the Common protocol, more specifically, question 11, had been discussed at length by listserv. The group had to decide whether the section should be deleted, shortened and amended, replace with validated SF-12 as initially discussed in earlier versions of the Common Protocol, or compile a few new questions.

The section was re-opened for discussion on a motion by Crystal Blyler, seconded by Matt Johnsen and a two-thirds affirmation vote.

The group discussed the fact that the SF-12 was not relevant to homeless people, but that it was too late to compose new questions without validation. Open-ended questions also rely heavily on the probing of the interviewer which added new concerns. The coordinating center and Sally Rogers noted the importance of having a health section, as it is encouraged by consultants and is important for evaluating cost-offsets, providing variables.

The motion to delete the Health Section was called by Tom Summerfelt, and seconded by Ruth Ralph. The motion was defeated 5 in favor, and 8 against, with 3 abstentions.

A new motion was proposed to keep the list of health questions, with an optional HIV section {those who chose not to use the HIV question would use the Other selection of the answer for gathering and recording this data. And the question would be moved to after the Hopkins Symptoms Checklist in the common protocol.

The motion was proposed by Matt Johnsen, and seconded by JoAnne O’Connor.

The housing section was reopened on a motion proposed by Matt Johnsen and seconded by Tom Summerfelt. It passed unanimously.

There was concern of the lack of a definition of homelessness within the questions proposed. In answer to the concerns within the entire section, the motion was separated into the four areas of concern and each was voted on individually.

Due to the concern that the list does not have categories that are exhaustive and understandable. The motion proposes adding two categories and changing four others to improve the list.

The recommendation to do this would be for Q1 p20, Q3 p21, Q5 p22, and Q 7 p 23 add the following two categories:

Your own trailer or mobile home (owned or rented)

Someone else's trailer or mobile home

and make the following amendments to categories:

e to read "Your own apartment or condo (owned or rented)"

f to read "Your own house (owned or rented)"

g to read "Someone else's apartment or condo"

h to read "Someone else's house"

There is concern with wording of several items, in that they may not be sufficiently sensitive to how persons who are homeless can answer these questions.

Specifically, rewording Question 12 on page 25 would address one concern.

Here there recommended rewording would read "How confident are you about your ability to pay for housing that is acceptable to you over the next twelve months?" (Response categories remain the same)

Steve Segal’s amendment was proposed and passed. The question was amended to read: " How confident are you of your ability to pay for housing over the next 12 months?"

b. The recommended rewording of Question 13 on page 25 would

read: [Note friendly amendment to b) on page 3]

IF HOUSED: How crowded do you feel in the space where you

Not at all crowded

IF ANY SHELTER AT NIGHT: How many people, if any, sleep in the

same room you do? Omit this question?

Motion to omit question 14 passed unanimously.

The motion was proposed Crystal Blyler, and seconded by Steve Segal.

Have a 4 month window timeframe only.

The group also decided that site-specific elements could be discussed at another meeting.

At this time the group voted to extend the meeting time by another half an hour, having exceeded meeting time.

Substance Use Section of the Common Protocol

The substance use questions had been posted and discussed on the listserv. A modified Addiction Severity Index (ASI) penned the ASI-Lite had been proposed by Danyelle Mannix , and was also discussed.

The section was re-opened for discussion on a motion by Ruth Ralph, and seconded by JoAnne O’Connor, with an objection by Crystal Blyler. The section was re-opened for discussion with 9 in favor, and 2 against.

It was noted that the changes affected questions 3-8, but the rest of the questions that helped assess cost data would remain in the common protocol.

After lengthy discussion, and with the need for members to have further review, the group decided to vote by listserv by 5pm on Tuesday, November 30^th. Danyelle Mannix would reformat the modified ASI-Lite with clearer instructions. Both formats would be re-published for review and voting.

In closing, Jean mentioned the need for discussion on the Records Release material, which would be needed for various data collection, especially the cost data.